MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; LAVAGE, JET

Catalog Number	00515047501
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is being recorded under (b)(4) as an initial/final report.G2: foreign - event occurred in japan.E1: telephone- (b)(6).Complaint can be confirmed through the returned product analysis.Functional testing of the returned product found the device would not power on with the original battery pack nor when connected to a lab battery pack.Visual inspection of the interior of the pack found the batteries had leaked electrolyte inside of the pack.There did not appear to be damage to the wiring of the pack.Visual inspection of the interior of the handpiece found the plunger was stuck in place inside the plunger housing.The motor would power on when the electrodes were made to touch in both trigger modes when connected to the lab battery pack.The device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to a manufacturing and/or design issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during surgery product didn't work even the motor from start and battery pack was getting hot.No serious injury and a 0-15 minute delay was noted.Upon evaluation of device at investigation it was noted that the batteries had leaked electrolyte.Diligence is complete as no additional info was noted.

• Brand Name: FAN SPRAY KIT
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24416554
• Report Number: 0001526350-2026-00194
• Device Sequence Number: 18784050
• Product Code: FQH
• UDI-Device Identifier: 00889024375161
• UDI-Public: (01)00889024375161(17)270506(10)77138269
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 00515047501
• Device Lot Number: 77138269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown